This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01680952
First received: September 4, 2012
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

Condition Intervention Phase
Kidney Transplant Patients Drug: A) TEST Drug: B) CONTROL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Failure rate in effectiveness of up to 12 months after kidney transplant [ Time Frame: 12 months after kidney transplant ]
    1. Biopsy confirmed acute rejection
    2. Subjects and graft survival
    3. Glomerular filtration rate (GFR)
    4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.


Enrollment: 158
Study Start Date: September 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A) TEST Drug: A) TEST
  1. Extended Release Tacrolimus (Advagraf®)

    ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.

    ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.

  2. Sirolimus (Rapamune®):

After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

Other Name: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)
Drug: B) CONTROL
  1. Extended Release Tacrolimus (Advagraf®)

    : Same as above.

  2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid
Other Name: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil
Experimental: B) CONTROL Drug: A) TEST
  1. Extended Release Tacrolimus (Advagraf®)

    ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.

    ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.

  2. Sirolimus (Rapamune®):

After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

Other Name: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)
Drug: B) CONTROL
  1. Extended Release Tacrolimus (Advagraf®)

    : Same as above.

  2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid
Other Name: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged over 20 years
  • Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
  • Patients has given written informed consent
  • Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
  • Patients has received an ABO compatible donor kidney.
  • Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

  • Patient has previously received an organ transplant other than a kidney.
  • Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
  • Desensitization
  • HLA-identical
  • Heart Disease; Heart failure (symptom, EF <45%)
  • Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
  • Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
  • malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
  • Patient has received a kidney transplant from non-heart beating donor
  • Cold ischemic time > 30hrs
  • Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
  • (ANC)<1,500/mm3, (WBC)<2,500/ mm3, (PLT)<100,000/ mm3
  • ATG: Anti-thymocyte globulin induction
  • Medical condition that could interfere with the study objectives.
  • Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
  • Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
  • Patient who is judged not to be adequate by the investigator owing to other reasons
  • Patient is pregnant or lactating.
  • Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680952

Locations
Korea, Republic of
Ajou Univeristy Medical Center
Suwon, KyungKi Province, Korea, Republic of
Kyungpook national hospital
Daegu, Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Gangnam Severance hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Seoul National University hospital
Seoul, Korea, Republic of
Ulsan Univ Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01680952     History of Changes
Other Study ID Numbers: 4-2011-0920
Study First Received: September 4, 2012
Last Updated: March 7, 2016

Keywords provided by Yonsei University:
RECORD study

Additional relevant MeSH terms:
Tacrolimus
Sirolimus
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on June 23, 2017